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Differentially Expressed Proteins in Sporadic Parathyroid Tumors

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ClinicalTrials.gov Identifier: NCT01647503
Recruitment Status : Unknown
Verified April 2014 by Sanjay K. Bhadada, Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Recruiting
First Posted : July 23, 2012
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Primary hyperparathyroidism (PHPT) is one of the common endocrine disorders. The major clinical symptoms involve stones, bones, abdominal groans and psychiatric moans. Increased parathyroid cell proliferation and decreased calcium-mediated control of the PTH secretion are characteristic findings. The most common cause of PHPT is adenoma followed by hyperplasia and carcinoma.The molecular mechanisms involved in parathyroid tumorigenesis are partially known. Few genes have been identified and their roles are under study.

The genes which are under study by different groups are unable to give a definite direction towards the understanding of parathyroid tumorigenesis and the mechanism involved in overgrowth of parathyroid tissue. So identifying different proteins and their regulation pattern from adenomas to carcinomas will be the initial steps towards understanding the proteins involved in tumorigenesis of parathyroid tissues. By using proteomics approach one can generate protein level information. In this study, using a combined approach based on 2 D gel electrophoresis and mass spectrometry (MS), the investigators propose to study a comparative proteomics to examine the changes of protein profiles in parathyroid tumor tissues with normal and hyperplasic parathyroid tissues. This work plan will help us to understand differentially expressed proteins in patients with PHPT. This will help in understanding the disease and identifying better diagnostic and curative measures of the disease. The investigators are also planning to access nuclear morphometry changes in sporadic parathyroid tumors. It will help in establishing cellular and nuclear change pattern variations from normal to parathyroid tumors.


Condition or disease
Primary Hyperparathyroidism Hypercalcemia

Detailed Description:

Subjects:

All the PHPT patients attending outdoor patient clinic of Endocrinology and General Surgery department of Nehru Hospital, PGIMER, Chandigarh will be enrolled in this study.

Sample collection:

A parathyroid tissue sample will be taken from the patients undergoing for parathyroidectomy. Samples will be collected immediately after surgery, snap frozen and stored at -80oC until use. In addition 10 ml of blood will also be taken from these patients for estimating biochemical parameters.

Controls:

Normal parathyroid gland will be used as control and it will be obtained from patient undergoing thyroidectomy for multinodular goiter as an elective procedure at the institute.


Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Identification of Differentially Expressed Proteins in Parathyroid Tumors and Their Clinical Correlation With the Disease
Study Start Date : July 2012
Estimated Primary Completion Date : September 2015


Groups and Cohorts

Group/Cohort
Tumor group
Parathyroid adenoma, hyperplasia and carcinoma
Normal
Normal parathyroid samples


Outcome Measures

Primary Outcome Measures :
  1. Differentially expressed proteins in parathyroid adenomas tissue samples [ Time Frame: At the end of three years of the study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients visiting the hospital for hypercalcemia, bone pain, renal problems and other symptoms related to primary hyperparathyroidim will be consider. Investigations and clinical symptoms will be confirmed for primary hyperpathyroidism. Finally if patient suggested for surgery then he will be included in the study
Criteria

Inclusion Criteria:

  • PHPT patients with parathyroid adenoma, hyperplasia and carcinoma

Exclusion Criteria:

  • Patients with family history, HPT-JT syndrome and familial isolated hyperparathyroidism
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647503


Contacts
Contact: Sanjay Kr Bhadada, DM bhadadask@rediffmail.com
Contact: Ashutosh Kr Arya, M Sc aryan.hcu@gmail.com

Locations
India
PGIMER Recruiting
Chandigarh, UT, India, 1600012
Principal Investigator: Sanjay Kr Bhadada, DM         
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Sanjay Kr Bhadada, DM Associate Professor, Department of Endocrinology, PGIMER Chandigarh India
More Information

Responsible Party: Sanjay K. Bhadada, Associate Professor, Dept of Endocrinology, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01647503     History of Changes
Other Study ID Numbers: parathyroid tumorigenesis
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: April 2014

Keywords provided by Sanjay K. Bhadada, Postgraduate Institute of Medical Education and Research:
parathyroid gland
primary hyperparathyroidism
proteins

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Hypercalcemia
Parathyroid Neoplasms
Parathyroid Diseases
Endocrine System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms